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S.K. Polymer Co., Ltd.

Thailand · Bangkok · skpolymer.com

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Australia — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

14listed device types

Class I 4Class II 10Class III 0

plus 35 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union4,967 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States35 registration records, 20 510(k), 0 PMA, 43 excluded

United Kingdom0 confirmed, 8 excluded

Brazil0 confirmed, 10 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: S & C POLYMER GMBH

FDA 510(k) clearances by year

11995

11998

51999

12000

52001

12003

12004

12008

42009

FDA listed device types

showing 8 of 14

Sealant, Pit And Fissure, And Conditioner 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Adhesive, Bracket And Tooth Conditioner, Resin 1Liner, Cavity, Calcium Hydroxide 1Material, Tooth Shade, Resin 1Material, Impression 1Crown And Bridge, Temporary, Resin 1

Market	Identifier	Name	Class / date
US	K091735	DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT	2009-09-25
US	K083062	ROOT CANAL XR	2009-03-12
US	K083766	PHOGLASS CEM	2009-03-02

S.K. Polymer Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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